Quality Assurance Assistant Manager

Description

Review and approval of Process validation Protocol and Report.

Review and approval of Scale Up plan, Engineering Batch Protocol and Report.

Review and approval of Exhibit Batch Protocol and Report.

Review and approval of Packing validation Protocol and Report.

Review of Master and Executed Batch Record (Validation, Scale-up, Exhibit, Engineering).

Handling of New Product Introduction activity.

Review and approval of protocol and Report as part of Investigation.

Review and approval of Hold time study protocol and Report.

Review and approval of Cleaning validation and verification protocol and Report.

SOP preparation, review, and approval.

Participation in Walkthrough & Self Inspection activity.

Preparation of Impact assessment & Risk assessment Documents.

Participation in Incident investigation, OOT & Out of Specification Investigation (phase II) activities.

Change control r...